Abstract
INTRODUCTION: Evidence on smokeless tobacco (ST) cessation interventions is scarce. The South Asian (SA) region that shares more than 90% of the burden of ST use is grossly underrepresented in research on ST cessation. This study aimed to assess the feasibility of delivering and investigating a behavioral support intervention for ST cessation in dental settings in Pakistan. METHODS: A multicenter, pilot, two-armed parallel-group, individually randomized control trial, with a 1:1 allocation ratio, was conducted at two dental hospitals. Eligibility criteria included being an ST user seeking dental treatment and not currently accessing cessation support. All participants were provided written self-help ST cessation material. The intervention group also received a dentist-delivered, bespoke behavioral support intervention for ST cessation developed for users of SA origin. Participants were followed up telephonically at 3 and 6 months. Self-reported 6-month abstinence was verified by salivary cotinine. Analysis was descriptive, with 95% confidence intervals presented where appropriate. RESULTS: One hundred participants were successfully recruited from the selected hospitals. Of these, 78% continued to engage throughout the study duration and provided primary outcome data, whereas 63% completed all hospital visits. The outcome measures were successfully collected. Biochemically verified 6-month abstinence in the intervention and control groups was 10% and 4%. CONCLUSIONS: It was feasible to deliver and evaluate a dentist-delivered behavioral support intervention for ST cessation in Pakistan. The data suggested that the intervention may improve ST quit rates. The findings of this study will be useful in informing the design of future definitive studies. IMPLICATIONS: To our knowledge, this is the first pragmatic pilot trial on ST cessation in dental settings in Pakistan and the first trial on dentist-delivered structured behavioral support intervention for ST cessation. It adds to the scarce, trial evidence based on ST cessation interventions. The findings suggest behavioral support intervention for ST cessation may improve quit rates. The trial was conducted in a country with poor ST control measures, where ST products are not taxed, the products are sold openly to and by minors, and the users are offered negligible cessation support. The findings may, therefore, be generalizable to low-middle-income countries, particularly SA countries, with similar policy backgrounds.